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March 12

Brexit Update: New Guidance from MHRA

In the event of no deal, the MHRA have released new guidance yesterday.  A wholesale dealer may import QP certified medicines from the EEA if certain checks are made by the Responsible Person (import) (RPi). Here’s a summary of what the guidance says on how to become a RPi and how to complete these checks:

How to Become a Responsible Person (Import)

Eligibility

To demonstrate that you are eligible to act as an RPi, you must have evidence of formal qualifications, experience and membership of professional bodies.  Of course, if you are already a person named on the Qualified Persons register you will also be eligible to act as a RPi; however, you must still apply to be named on the RPi register.

Suitability

In addition to eligibility, the MHRA will confirm your suitability to be named on a specific WDA(H) licence.  The example they provide is an eligible RPi without prior experience in parallel importation might not be considered suitable to be named on a WDA(H) where the company is importing licensed products for parallel trade.

RPi application may be submitted through the MHRA Portal after the UK leaves the EU.

How to Complete Checks for QP Certification

The RPi is responsible for implementing a system that confirms the required QP certification has taken place for products imported into the UK from the EEA. Acceptable written evidence that confirms QP certification has taken place for the batch in question could be one of the following:

  • Batch certificate
  • A copy of the ‘control report’
  • Statement of certification
  • Reference to company internal systems
  • Confirmation of the final manufacturing step (other than batch certification)
  • Confirmation of purchase from an authorised wholesaler after it has been ‘placed on the market’ in the listed country

To read the guidance in full, please click here.

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About the Author

Theresa Webster is the Marketing Director at Broughton Laboratories. After studying at the University of North Carolina at Charlotte receiving a BSc in Biology and a BA in Chemistry, Theresa began her career here at Broughton Laboratories, as a Commercial Projects Manager. She developed business start-ups from idea to fully operational divisions, in particular, the stability storage facility and software services. Theresa led the software services division to become a stand-alone business in 2012 as Broughton Software providing the industry's leading LIMS solution for Quality Control Laboratories. She has rejoined the team at Broughton Laboratories in 2018 with a focus to ensure the customer's evolving needs are continually met by our services.